Medical Device News

Attune Medical and Heart Rhythm Clinical Research Solutions (HRCRS) Collaborate with Real World Evidence Consortium Members to Evaluate ensoETM™ in High Volume Centers

Real world study will investigate throughput and patient experiences with proactive esophageal cooling

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Attune Medical and Heart Rhythm Clinical Research Solutions (HRCRS) are partnering on an evaluation of Attune’s ensoETM thermal regulating device through the HRCRS Real World Evidence (RWE) consortium. HRCRS will conduct a multi-center observational study through the RWE network of high-volume cardiac electrophysiology centers to collect data on the ensoETM’s effect on throughput and patient outcomes.

The RWE consortium consists of approximately 50 US high-volume electrophysiology centers that perform procedures such as cardiac radiofrequency ablation for the treatment of atrial fibrillation. Participating members will deploy the use of the ensoETM and collect and report data back to HRCRS for the clinical study.

Heart Rhythm Clinical Research Solutions is a Contract Research Organization (CRO) specializing in connecting industry clients to the right cardiac electrophysiologists and infrastructural support to conduct the most productive, efficient, and cost-effective research possible. Through strategic relationships with the organizations where network physicians practice, HRCRS streamlines the contracting, initiation, site management and data collection efforts.

“There’s enormous potential for esophageal temperature management with ensoETM to become a best practice in our industry,” commented Jose Osorio, MD, a leading electrophysiologist and President of HRCRS. “By leveraging the talent and expertise of our network members to further evaluate the ensoETM in real-time practice, we look forward to moving the use of this promising technology forward.”

“As a current user of ensoETM, and as a member of the HRCRS RWE consortium, I am excited to support further adoption of this technology,” added Mark Metzl, MD, FHRS, Section Chief, Cardiac Electrophysiology, with NorthShore University Health System. “Our experience with ensoETM has been remarkable – published studies from our system have shown improved patient outcomes and greater procedural efficiency.”

“It’s an honor to be working with the HRCRS network to collect data on the use of ensoETM,” commented Jay Istvan, CEO of Attune Medical. “HRCRS has a long-standing commitment to advancing best practices in the field, and we are excited to get started.”

The US FDA recently granted an Investigational Device Exemption (IDE) to Attune to evaluate the company’s ensoETM in the reduction of esophageal thermal injury during cardiac radiofrequency ablation procedures. Several published studies have examined the use of ensoETM for this purpose, including the IMPACT single-center study and the pilot eCOOL-AF study. Most recently, a large multi-center review of over 25,000 patients was completed.

Attune Medical’s ensoETM is a single use thermal regulating device that is placed in the esophagus (similar to a standard orogastric tube) and connected to an external heat exchange unit, creating a closed-loop system for heat transfer to increase or decrease patient temperature. Its placement in the esophagus, with proximity to blood flow from the heart and great vessels, allows highly efficient heat transfer. Unlike surface warming devices, ensoETM‘s internal placement doesn’t impede patient access during surgery and allows gastric decompression and administration of fluids and medications.

Attune Medical’s novel medical device technology simplifies access to the patient’s core to efficiently control temperature and is the only device FDA-cleared for use in the esophagus for patient temperature management. The ensoETM device is used in critical care units, operating rooms, and emergency departments for the intentional modulation of patient core temperature and can be rapidly placed by most trained healthcare professionals.

The ensoETM has been cleared by the FDA to control patient temperature. The ensoETM has NOT been approved or cleared by the FDA to reduce thermal injury to the esophagus during radiofrequency cardiac ablation procedures.

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